Positive results from Revita DMR System study

The results from a 39-patient, single-site, proof-of-concept study has demonstrated that a minimally invasive procedure using the Revita Duodenal Mucosal Resurfacing (DMR) System (Fractyl Laboratories) produces significant, beneficial changes in blood sugar in patients with poorly controlled type 2 diabetes, similar to results seen with more invasive bariatric surgery procedures. The outcomes, presented by Dr Alan D Cherrington, Professor of Medicine and Molecular Physiology and Biophysics at Vanderbilt University, were presented at the 3rd World Congress on Interventional Therapies for Type 2 Diabetes and 2nd Diabetes Surgery Summit in London, UK.

“I appreciate having the opportunity to present our data. Patients in this study had poorly controlled type 2 diabetes, despite medication use. They experienced a significant improvement in HbA1c after this minimally invasive procedure, as well as some weight loss,” said Cherrington. “With this study, we continue to see evidence that the biology of the intestine plays a very important role in type 2 diabetes pathology, and that altering it can meaningfully improve blood sugar control.”

Fractyl has developed a minimally invasive, device-based, implant-free Revita DMR procedure that directly addresses the intestinal hormonal impairment that contributes to insulin resistance and changes how the body absorbs and processes sugar. Revita DMR is an endoscopic procedure that thermal ablates the duodenal mucosa. The company claims procedure has the potential to delay the need for insulin therapy and free patients from the burdens associated with managing type 2 diabetes, particularly when oral medications have failed.

The Revita device allows physicians to easily separate the mucosal layer of the duodenum from the sub-muscosa

In the proof-of-concept study, 39 patients with poorly controlled type 2 diabetes (HbA1c > 7.5% on at least 1 oral anti-diabetic agent) received DMR on a long-segment (> 9 cm; LS-DMR; n=28) or a short segment (< 6 cm; SS-DMR; n=11) of the duodenum. The primary endpoints were safety and reduction in HbA1c, assessed over a follow-up period of 6 months.

After the mucosal layer is separated, the ablation balloon catheter is delivered into the duodenum

Baseline mean HbA1c (9.5 percent) was reduced more by LS-DMR than SS-DMR at 3 months post-procedure, suggesting a dose-dependent treatment effect from DMR (p<0.05 for LS vs SS). In LS-DMR patients with baseline HbA1c of 7.5 to 10 percent and stable concomitant anti-diabetic medications, HbA1c after LS-DMR decreased from 8.5 percent to 7.1 percent (p<0.05) at 6 months, accompanied by a modest weight reduction of 2.3 kg. There was no apparent correlation between degree of weight loss and magnitude of HbA1c improvement. Three patients experienced duodenal stenosis that required endoscopic balloon dilation, all with good resolution.

“Earlier this month, our team published a five-year follow-up study showing that surgery may be more effective than standard medical treatments for the long-term control of type 2 diabetes in obese patients,” said Professor Francesco Rubino, Chair of Bariatric Surgery at King’s College London and Consultant Surgeon at King’s College Hospital in London, UK. “This is a huge shift in how we think about the disease. It will be exciting to see if these early results using a much less invasive duodenal mucosal resurfacing approach will be reproduced in larger studies.”

In July 2015, Fractyl announced the start of the Revita-1 study, which will enroll 50 patients across ten international sites in its first phase. The primary efficacy endpoint is change in HbA1c in patients with uncontrolled type 2 diabetes, defined as having poor glucose control on oral medications and an HbA1c of 7.5 to 10 percent. To date, 20 patients have been treated in the Revita-1 study. The second phase of the study, a double-blinded, sham-controlled trial that will enroll up to 240 patients, will begin in 2016.

“These results are helpful as we design our path to market, including pivotal trials in Europe and the United States,” said Dr Harith Rajagopalan, Co-Founder and CEO of Fractyl. “It is exciting to have our data presented at WCITT2D in context of the spectrum of novel intervention therapies for type 2 diabetes.”

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